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临床试验/NCT03489577
NCT03489577终止不适用

The Role of Post-traumatic Inhibition of the Innate and Adaptive Immune System in the Development of Infectious Complications in Severely Injured Patients

UMC Utrecht1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
UMC Utrecht
入组人数
15
试验地点
1
主要终点
Bactericidal capacity of neutrophils and sepsis

研究概览

简要总结

Patients admitted to the Intensive Care Unit after severe injury are prone to suffer from infectious complications and even sepsis. Despite tremendous efforts the etiology of this increased susceptibility to infectious pathogens is incompletely understood. Clinical signs and symptoms as well as current diagnostic clinical tests (WBC, CRP, cytokines, interleukines) lack sensitivity or specificity for adequate prediction of the development of infectious complications or sepsis.

Neutrophil granulocytes, cells of the innate immune system, play an important role in the defence against invading bacterial pathogens and are crucial in preventing fulminant infections. For successful eradication of a bacterium neutrophils need to exert specific functions: chemotaxis, migration, phagocytosis, degranulation and production of radical oxygen species. Much research has focused on the effect of trauma on neutrophil's individual capacities to kill bacteria with conflicting interpretations as a result. For adequate determination of the neutrophil's capacity to eradicate bacteria from tissue of trauma patients we developed novel in-vitro assays in which neutrophils are tested for all of these functions combined. This assay allows us to identify dysfunctional neutrophils adequately.

The main focus of this study is the determination of the functionality of aberrant neutrophils circulating in the peripheral blood of severly injured following trauma.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Admitted to the ICU
  • Expected stay of at least 2 days
  • Age: 18 - 80 years
  • Informed consent (when proxy consent is obtained and the patient leaves the ICU in good mental health, personal informed consent is additionally necessary)

排除标准

  • Immunosuppressive medication
  • HIV and related diseases

结局指标

主要结局

Bactericidal capacity of neutrophils and sepsis

时间窗: 15 days following admission on ICU

The correlation between reduced bactericidal capacity of neutrophils acquired from severely injured patients and the late occurrence of sepsis

次要结局

  • Bactericidal capacity of neutrophils and pro-inflammatory complications(15 days following admission to the ICU)
  • Bactericidal capacity of neutrophils and infectious complications(15 days following admission to the ICU)
  • T-cell proliferation and infectious complications(15 days following admission on ICU)
  • Priming capacity of neutrophils and infectious complications(15 days following admission on the ICU)
  • Complement system and infectious complications(15 days following admission to the ICU)

研究者

发起方
UMC Utrecht
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. dr Leenen

Prof. Dr.

UMC Utrecht

研究点 (1)

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